FDA Enforcement
Class I
Ongoing
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Recall: Z-1519-2024
·
Reported April 24, 2024
Enforcement
- Recall Number
- Z-1519-2024
- Event ID
- 94292
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SonarMed Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 24, 2024
- Initiation Date
- March 21, 2024
- Classification Date
- April 18, 2024
- Address
- 12220 N Meridian St Ste 150, Carmel, IN, 46032-6972, United States
Description
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Reason
The failure to detect the partial obstruction in a 2.5mm sensor.
Code Info
Product Number/CFN: AW-S025; UDI-DI: 10851334007183; Serial Numbers: A20221012, A20221018, A20221025, A20221107, A20221109, A20221202, A20221206, A20221207, A20221208, A20221209, A20230105, A20230109, A20230123, A20230124, A20230125, A20230126, A20230213, A20230224, A20230228, A20230301, A20230302, A20230303, A20230320, A20230324, A20230411, A20230724, A20230725.
Distribution
Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
Quantity
610 units